Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT03975335
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2019-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Behavioral Risk Factors of NCDs: Protocol for a School-based Health Education Program in Bangladesh
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012309', 'term': 'Risk-Taking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 823}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-01', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-06-01', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in knowledge', 'timeFrame': 'Three months', 'description': 'Knowledge about non-communicable diseases related risk behaviors such as dietary habit, physical activity, smoking and alcohol will be measured by 25 knowledge measuring questions scoring 54 in total. Answer to the questions will be regarded as correct or incorrect based on information from standard medical textbooks and guidelines. Difference of knowledge score from pre-intervention to post-intervention survey will be measured.'}, {'measure': 'Change in attitude', 'timeFrame': 'Three months', 'description': 'Attitude towards the risk behaviors- dietary habit, physical activity, smoking and alcohol will be measured by nine attitude measuring questions in a Likert Scale ranging from one to three. Change in attitude score from pre-intervention to post-intervention survey will be measured.'}, {'measure': 'Change in practice', 'timeFrame': 'Three months', 'description': 'Practice will be measured as follows-\n\n1. Dietary habit: Presence of at least two of the following four habits will be accounted as having dietary risk behavior.\n\n i. Inadequate fruit consumption: Less than five servings of fruits per day ii. Inadequate vegetable consumption: Less than five servings of vegetables per day iii. Excessive salt consumption: Taking extra or raw salt during every meal iv. Sugar Sweetened Beverage (SSB) consumption: Consuming SSB more than three days per week\n2. Physical activity: Not meeting 60 minutes physical activity of moderate intensity per day will be regarded as physically inactive.\n3. Smoking and alcohol: Smoking regularly in the last 30 days or exposing to passive smoking more than three days per week will be accounted as in risk of smoking. Any amount of alcohol intake or any substance abuse in the last 30 days will be regarded as at risk.\n\nChange in practice from pre-intervention to post-intervention survey will be measured.'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Three months', 'description': 'The ratio of body weight in kilogram and the height in meter square will be considered as BMI. Classification of BMI will be done as following- Underweight (Less than 18.5); Normal weight (18.5-24.9); Overweight (25.0-29.9) and Obese (More than 30.0)'}, {'measure': 'Blood Pressure', 'timeFrame': 'Three months', 'description': 'Blood pressure will be measured by an automatic digital sphygmomanometer (HEM-8712, Omron, Kyoto, Japan). Presence of systolic blood pressure ≥ 130 mm of Hg and/or diastolic blood pressure ≥ 80 mm of Hg will be considered as having high blood pressure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NCDs', 'Risk behaviors', 'Adolescents', 'Health education intervention'], 'conditions': ['Non-communicable Disease Risk Factors']}, 'referencesModule': {'references': [{'pmid': '34101740', 'type': 'DERIVED', 'citation': 'Salwa M, Subaita F, Choudhury SR, Khalequzzaman M, Al Mamun MA, Bhuiyan MR, Haque MA. Fruit and vegetables consumption among school-going adolescents: Findings from the baseline survey of an intervention program in a semi-urban area of Dhaka, Bangladesh. PLoS One. 2021 Jun 8;16(6):e0252297. doi: 10.1371/journal.pone.0252297. eCollection 2021.'}, {'pmid': '31345186', 'type': 'DERIVED', 'citation': 'Salwa M, Atiqul Haque M, Khalequzzaman M, Al Mamun MA, Bhuiyan MR, Choudhury SR. Towards reducing behavioral risk factors of non-communicable diseases among adolescents: protocol for a school-based health education program in Bangladesh. BMC Public Health. 2019 Jul 25;19(1):1002. doi: 10.1186/s12889-019-7229-8.'}]}, 'descriptionModule': {'briefSummary': 'This is a before-after designed intervention study conducted in two randomly selected secondary schools- one was selected randomly as intervention school and the another as control school. A baseline survey was conducted among the students of both schools by a pre-tested questionnaire to attain their current status of knowledge, attitude and practices related to NCDs. Afterward, students were enrolled in the intervention group who met the eligibility criteria from the intervention school. The intervention was given through a health promotion session to a group of students, not more than 25 at a time, by trained facilitators. A post-intervention end line survey was conducted among all the participants from both schools using the same questionnaire three months after the baseline survey. An intervention has been developed based on some principals of two psychosocial theory- Motivational Interview and Social Cognitive Theory. Emphasis was given on motivating the adolescents towards a healthy lifestyle, supporting self-efficacy to be changed, guiding self-regulatory ways along with facilitating desired changing process by empowering them with choices about the preventive measures of NCDs. This intervention is expected to increase awareness by equipping the adolescents with specific knowledge and skills and thus, facilitate an eventual change in their practiced risk behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Practicing at least two risk behaviors from three- unhealthy diet, physical inactivity and smoking\n\nExclusion Criteria:\n\n• Physically disabled or having limited movement'}, 'identificationModule': {'nctId': 'NCT03975335', 'briefTitle': 'Reducing Behavioral Risk Factors of NCDs: Protocol for a School-based Health Education Program in Bangladesh', 'organization': {'class': 'OTHER', 'fullName': 'Chi Research & Infotec Ltd.'}, 'officialTitle': 'An Intervention Program to Reduce NCD Related Behavioral Risk Factor Among Adolescents in Institutional Settings of Bangladesh', 'orgStudyIdInfo': {'id': 'BSMMU/2018/5958'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Health education on NCDs and behavioral risk factors was delivered through motivation and observational learning session.', 'interventionNames': ['Behavioral: Health education']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Control group received session on carrier guidance.', 'interventionNames': ['Other: Carrier Guidance']}], 'interventions': [{'name': 'Health education', 'type': 'BEHAVIORAL', 'description': "In this health education intervention, emphasis is given on evoking adolescents' internal desire to change, supporting self-efficacy to be changed, guiding self-regulatory ways along with facilitating desired changing process by empowering them with choices and skills.", 'armGroupLabels': ['Intervention group']}, {'name': 'Carrier Guidance', 'type': 'OTHER', 'description': 'Carrier opportunities and counselling', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Chi Research & Infotec Ltd.', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Md Khalequzzaman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, {'name': 'Sohel Reza Choudhury, DrPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Heart Foundation Hospital and Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study protocol, statistical analysis plan and informed consent form will be shared through'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chi Research & Infotec Ltd.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Directorate General of Health Services', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}